Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207925

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KALYDECO (IVACAFTOR)
25MG/PACKET
Marketing Status: Prescription

Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 25MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207925
Product Number: 003
Approval Date: Apr 29, 2019
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

KALYDECO (IVACAFTOR)
50MG/PACKET
Marketing Status: Prescription

Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 50MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207925
Product Number: 001
Approval Date: Mar 17, 2015
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

KALYDECO (IVACAFTOR)
75MG/PACKET
Marketing Status: Prescription

Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 75MG/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207925
Product Number: 002
Approval Date: Mar 17, 2015
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information